dualFETboost: FET-PET Directed Simultaneous In-field Boost for Primary GBM

Sponsor

Prof. Franciszek Lukaszczyk Memorial Oncology Center (Other)

Overall Status

Completed

CT.gov ID

NCT04790097

Collaborator

(none)

Enrollment

Location

Arm

46.3

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition.

In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost	N/A

Detailed Description

In the case of the treatment of glioblastoma multiforme, as a standard, radiotherapy lasts 6 weeks, and the extension of treatment may adversely affect the tumor cells death, the patient's well-being and treatment costs (prolonged hospitalization). In turn, escalating the dose may increase the toxicity of radiation therapy by increasing DNA damage in healthy brain tissue. Using of dual FET-PET images for treatment planning allow to reduce volumes of healthy tissue irradiated. Dose-intensification proposed in the study using simultaneous in-field boost allows the dose escalation without increasing the overall treatment time. All patient will be treated with moderately hypofractionated radiotherapy (2.6 Gy per fraction) directed on PET positive volumes and conventional fractionation (60Gy in 30 fractions) on tumor margin.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide

Actual Study Start Date :

Feb 21, 2017

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simultaneous In-Field Boost on FET-PET positive target volumes	Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost 78Gy in 30 fractions on FET-PET based target volumes; 60Gy in 30 fractions on 2cm margin from MRI based target volumes; all patients will be treated with concomitant and adjuvant temozolomide

Arm

Intervention/Treatment

Experimental: Simultaneous In-Field Boost on FET-PET positive target volumes

Radiation: Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost

78Gy in 30 fractions on FET-PET based target volumes; 60Gy in 30 fractions on 2cm margin from MRI based target volumes; all patients will be treated with concomitant and adjuvant temozolomide

Outcome Measures

Primary Outcome Measures

Overall survival [assessed up to 24 months]
From date of surgery until the date of death from any cause, percent of patient that are alive 1 and 2 years after surgery

Secondary Outcome Measures

Progression Free Survival [up to 24 months]
from the date of surgery until progression of the disease or the date of death from any cause assessed
Objective response [up to 9 months]
according to Rano criteria; from the end of radiation therapy
Location of treatment failure [up to 24 months]
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; according to irradiation field
Radiation necrosis [assessed up to 24 months]
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; histopathological diagnosis of radiation necrosis
Side effects [up to 6 months]
from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; CTCAE grade 3 or higher

Other Outcome Measures

FET predictive value [up to 24 months]
From date of surgery until the date of death from any cause, Correlation between FET uptake and survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histopathological confirmation of glioblastoma (WHO grade IV)
Age between 18-75 years of age
General condition according to the Zubrod scale 0 or 2
The results of the blood counts are normal
Liver enzyme parameters normal
The results of the parameters of the patient's functions are normal
Informed consent to participate in the category

Exclusion Criteria:

Coexistence of another cancer
The location of the tumor in the area of the brain stem or cerebellum
Prior brain radiation therapy
No uptake visible in the FET-PET imaging
Contraindications for MRI
Contraindications to radiotherapy or chemotherapy
Pregnancy, lack of consent to the use of protection against pregnancy, puerperium
Alcohol addiction
Mental illness
Claustrophobia